Back to results

Clinical Study of Stent Versus Direct Atherectomy Versus Angioplasty to Treat Lower Limb In-stent Restenosis

Primary Purpose

Atherosclerosis, In-stent Arterial Restenosis

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

plaque excision system

stent

Balloon

About this trial

This is an interventional treatment trial for Atherosclerosis focused on measuring stents, atherectomy, femoral artery, popliteal artery, In-stent Restenosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Provides written informed consent Willing to comply with follow-up evaluations at specified times Has claudication or rest pain due to peripheral arterial In-stent restenosis Disease located within the femoropopliteal artery Patient has a In-stent restenosis lesion(s) with >50% stenosis documented angiographically Patient has symptoms of peripheral arterial disease classified as Rutherford Category 2 or greater.

Exclusion Criteria:

They were excluded if they had one or more of the following: 1. Acute or subacute lower limb ischemia; 2. Severe calcification lesions; 3. Total occlusions lesions more significant than 10 cm or total occlusion lesions with a suspicion of subintimal wire recanalization 4. untreated ipsilateral iliac artery stenosis>70%, or the distal runoff artery <1 root; 5. Previously lower extremity intervention or surgical graft artery bypass; 6. Severe renal insufficiency, creatinine level greater than 2.5 mg/dL; 7. The patient's platelet count is less than 100,000/uL, antiplatelet or anticoagulant contraindications to required medications; 8. Patients with immune system diseases or malignant tumours; 9. ongoing active infection 10. decompensated congestive heart failure or acute coronary syndrome; 11. Unwillingness to return for future follow-up visits

Sites / Locations

Gu Yong QuanRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Intervention: Stents

Intervention: Atherectomy

Intervention: Balloon

Arm Description

Stents group

Direct Atherectomy group

Balloon group

Outcomes

Primary Outcome Measures

Primary Patency Rate

Primary patency is defined as no significant reduction of flow detectable by Duplex ultrasound through the index lesion and no further clinically driven target vessel revascularization performed in the interim. Significant reduction of flow is binary restenosis defined as the diameter stenosis >50% with a peak systolic velocity ratio >2.4 as measured by Duplex ultrasound.

Secondary Outcome Measures

Technical success

Technical success is defined as residual stenosis less than 30% by final angiography and/or a flow-limiting dissection.

freedom from clinically-driven TLR

it is defined as freedom from clinically-driven target lesion revascularization

Major Adverse Events

Major adverse events included death, index limb ischemia, index limb amputation, clinically driven target lesion revascularization, and significant embolic events, which were defined as causing end-organ damage.

Limb Salvage Rate

Limb Salvage is defined as the freedom from secondary major amputation

Full Information

NCT ID

NCT02832024

First Posted

September 14, 2015

Last Updated

December 2, 2019

Sponsor

Xuanwu Hospital, Beijing

1. Study Identification

Unique Protocol Identification Number

NCT02832024

Brief Title

Clinical Study of Stent Versus Direct Atherectomy Versus Angioplasty to Treat Lower Limb In-stent Restenosis

Study Type

Interventional

2. Study Status

Record Verification Date

May 2019

Overall Recruitment Status

Unknown status

Study Start Date

January 2016 (undefined)

Primary Completion Date

December 2019 (Anticipated)

Study Completion Date

December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Xuanwu Hospital, Beijing

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This is a randomized study comparing Stent Versus Direct Atherectomy Versus Angioplasty to Treat Lower Limb In-stent Restenosis (superficial femoral or popliteal artery).

Detailed Description

This is a randomized study comparing Stent Versus Direct Atherectomy Versus Angioplasty to Treat Lower Limb In-stent Restenosis (superficial femoral or popliteal artery).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atherosclerosis, In-stent Arterial Restenosis

Keywords

stents, atherectomy, femoral artery, popliteal artery, In-stent Restenosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intervention: Stents

Arm Type

Active Comparator

Arm Description

Stents group

Arm Title

Intervention: Atherectomy

Arm Type

Active Comparator

Arm Description

Direct Atherectomy group

Arm Title

Intervention: Balloon

Arm Type

Active Comparator

Arm Description

Balloon group

Intervention Type

Device

Intervention Name(s)

plaque excision system

Intervention Type

Device

Intervention Name(s)

stent

Intervention Type

Device

Intervention Name(s)

Balloon

Primary Outcome Measure Information:

Title

Primary Patency Rate

Description

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Technical success

Description

Technical success is defined as residual stenosis less than 30% by final angiography and/or a flow-limiting dissection.

Time Frame

1 day

Title

freedom from clinically-driven TLR

Description

it is defined as freedom from clinically-driven target lesion revascularization

Time Frame

12 months

Title

Major Adverse Events

Description

Time Frame

12 months

Title

Limb Salvage Rate

Description

Limb Salvage is defined as the freedom from secondary major amputation

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Provides written informed consent Willing to comply with follow-up evaluations at specified times Has claudication or rest pain due to peripheral arterial In-stent restenosis Disease located within the femoropopliteal artery Patient has a In-stent restenosis lesion(s) with >50% stenosis documented angiographically Patient has symptoms of peripheral arterial disease classified as Rutherford Category 2 or greater. Exclusion Criteria: They were excluded if they had one or more of the following: 1. Acute or subacute lower limb ischemia; 2. Severe calcification lesions; 3. Total occlusions lesions more significant than 10 cm or total occlusion lesions with a suspicion of subintimal wire recanalization 4. untreated ipsilateral iliac artery stenosis>70%, or the distal runoff artery <1 root; 5. Previously lower extremity intervention or surgical graft artery bypass; 6. Severe renal insufficiency, creatinine level greater than 2.5 mg/dL; 7. The patient's platelet count is less than 100,000/uL, antiplatelet or anticoagulant contraindications to required medications; 8. Patients with immune system diseases or malignant tumours; 9. ongoing active infection 10. decompensated congestive heart failure or acute coronary syndrome; 11. Unwillingness to return for future follow-up visits

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

li yang

Phone

17198643706

First Name & Middle Initial & Last Name or Official Title & Degree

Gu yongquan

Phone

+186-010-83198647

Facility Information:

Facility Name

Gu Yong Quan

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100053

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yang Li, M.D.

Phone

17198643706

liyang0603@aliyun.com

First Name & Middle Initial & Last Name & Degree

Yong quan Gu, M.D.

Phone

15901598209

15901598209@163.com

12. IPD Sharing Statement

Plan to Share IPD

Yes

Citations:

PubMed Identifier

23822938

Citation

Yongquan G, Lianrui G, Lixing Q, Xuefeng L, Zhu T, Shijun C, Yingfeng W, Jianming G, Jian Z, Zhonggao W. Plaque excision in the management of lower-limb ischemia of atherosclerosis and in-stent restenosis with the SilverHawk atherectomy catheter. Int Angiol. 2013 Aug;32(4):362-7.

Results Reference

background

Learn more about this trial

Clinical Study of Stent Versus Direct Atherectomy Versus Angioplasty to Treat Lower Limb In-stent Restenosis

We'll reach out to this number within 24 hrs